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FDA 510(k)

CoLumbo C-Spine

K-Number: K254015 · 2026-04-01

ApplicantSmart Soft Healthcare AD
Decision Date2026-04-01
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CoLumbo C-Spine is a medical device manufactured by Smart Soft Healthcare AD. It received FDA 510(k) clearance on 2026-04-01 under approval number K254015. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoLumbo C-Spine?

CoLumbo C-Spine is a medical device that received FDA 510(k) clearance on 2026-04-01. It is manufactured by Smart Soft Healthcare AD. The 510(k) number is K254015.

When was CoLumbo C-Spine approved by the FDA?

CoLumbo C-Spine received FDA 510(k) clearance on 2026-04-01, under approval number K254015.

What company makes CoLumbo C-Spine?

CoLumbo C-Spine is manufactured by Smart Soft Healthcare AD.

What is the FDA product code for CoLumbo C-Spine?

The FDA product code for CoLumbo C-Spine is QIH.

Other Devices by Smart Soft Healthcare AD

K220497CoLumbo K250367CoLumboX

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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